Abiraterone, Enzalutamide
Proposed amendment to existing PBS listings for castration resistant prostate cancer to remove the requirement that disease be metastatic; previously restricted to metastatic CRPC (mCRPC) following docetaxel failure or unsuitability.
From the public summary
5.1 The PBAC did not recommend amending the existing abiraterone and enzalutamide restrictions for castration resistant prostate cancer (CRPC) to remove the criteria that the disease be metastatic.PSD · Jul 2021
5.2 The PBAC noted that abiraterone is not TGA registered for use in CRPC patients without metastatic disease. The PBAC noted the sponsor’s comments that: 4PSD · Jul 2021
Cost-effectiveness
This is a resubmission of a listing restriction amendment. No new economic evaluation was performed; the submission concerned a change to clinical criteria only.
Decision context
PopulationPatients with castration-resistant prostate cancer (CRPC); proposed amendment would have extended eligibility to non-metastatic CRPC (m0CRPC) without the prior docetaxel or unsuitability-for-docetaxel requirement.
Why it was knocked back
- abiraterone not TGA-registered for non-metastatic CRPC; safety concerns with prolonged prednisone use in earlier disease; no clinical trial evidence for NHAs in low-risk m0CRPC; complex to craft restriction targeting high-risk patients; sponsors did not provide financial impact estimate
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Not recommended | — | — | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line CRPC; TGA labels include earlier-line mCRPC and newly diagnosed high-risk metastatic HSPC.